ROCHE COBAS AMPLICOR ANALYZER

Analyzer, Chemistry, Micro, For Clinical Use

ROCHE MOLECULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Cobas Amplicor Analyzer.

Pre-market Notification Details

Device IDK964506
510k NumberK964506
Device Name:ROCHE COBAS AMPLICOR ANALYZER
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
ContactAlex Wesolowski
CorrespondentAlex Wesolowski
ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3711
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-08
Decision Date1997-05-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.